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Neuroprosthetic Device

Neuroprosthetic System for Spinal Cord Injury (NNP-UE+T Trial)

N/A
Recruiting
Research Sponsored by Kevin Kilgore
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age > 16 years
Diagnosis of cervical level spinal cord injury, either complete or incomplete; International Standards for Neurological Classification of Spinal Cord Injury (INCSCI) motor level of C4 through C8; American Spinal Injury Impairment Scale (AIS) grade A, B, C, or D; six months or more post-injury
Must not have
Unhealed fractures that prevent functional use of arm or trunk
Active untreated infection such as decubitus ulcer, urinary tract infection, pneumonia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-implant and three months post-implant
Awards & highlights
No Placebo-Only Group

Summary

This trial is to test a new, fully implanted device that could help people with cervical spinal cord injuries regain hand function, reach, and trunk function. It is funded by the FDA, NIH, and NINDS.

Who is the study for?
This trial is for individuals over 16 years old with cervical spinal cord injuries (C4-C8 level, AIS grade A-D) who are at least six months post-injury. Participants must have some arm and trunk muscle strength, be medically stable for surgery, and willing to participate. Pregnant women, those with certain neurological conditions or severe diseases, active infections, or other implantable devices are excluded.
What is being tested?
The study tests a fully implanted neuroprosthetic system designed to restore hand function, reach ability, and trunk control in people with cervical spinal cord injuries. It aims to evaluate the device's effectiveness in improving motor functions that were affected by the injury.
What are the potential side effects?
While specific side effects aren't listed here, potential risks may include surgical complications like infection or bleeding; device malfunction; discomfort; adverse reactions from the body towards the implant; and possible interference with other electronic devices.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am older than 16 years.
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I have a spinal cord injury at the neck level and it's been over 6 months since the injury.
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My arm and trunk muscles respond well to stimulation.
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I can move my arm and some upper body muscles with some strength.
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I can move my arm against gravity.
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I am medically cleared for surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have fractures that stop me from using my arm or body properly.
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I currently have an untreated infection like a skin ulcer, UTI, or pneumonia.
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I have a neurological condition like multiple sclerosis or diabetes affecting my nerves.
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I do not have severe heart, lung, blood clotting disorders, HIV, or severe slow heart rate.
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I have significant nerve damage in my upper limbs.
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My spinal cord injury is getting worse and I am getting implants on both sides.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~three months post-implant
This trial's timeline: 3 weeks for screening, Varies for treatment, and three months post-implant for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Activities of Daily Living Abilities Test
Secondary study objectives
Grasp-Release Test

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Intervention - implant neuroprosthesisExperimental Treatment1 Intervention
Receives implanted networked neuroprosthetic system for hand, arm, and trunk function. Undergoes functional training and assessment.

Find a Location

Who is running the clinical trial?

National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,373 Previous Clinical Trials
650,914 Total Patients Enrolled
Congressionally Directed Medical Research ProgramsFED
54 Previous Clinical Trials
9,591 Total Patients Enrolled
Case Western Reserve UniversityOTHER
307 Previous Clinical Trials
248,173 Total Patients Enrolled

Media Library

Networked Neuroprosthetic System for Grasp and Trunk (Neuroprosthetic Device) Clinical Trial Eligibility Overview. Trial Name: NCT02329652 — N/A
Spinal Cord Injury Research Study Groups: Intervention - implant neuroprosthesis
Spinal Cord Injury Clinical Trial 2023: Networked Neuroprosthetic System for Grasp and Trunk Highlights & Side Effects. Trial Name: NCT02329652 — N/A
Networked Neuroprosthetic System for Grasp and Trunk (Neuroprosthetic Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02329652 — N/A
Spinal Cord Injury Patient Testimony for trial: Trial Name: NCT02329652 — N/A
~2 spots leftby Aug 2025
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